For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that are critical to a product’s sterility including inappropriately qualified and trained personnel required as key staff to implement a fully compliant sterilization process.
This can potentially lead to Product Failures (Sterility Failures), product Non-conformances, Product Recalls, FDA’s Warning Letters, Consent Decrees and discontinuance of commercial operations which may negatively impacts a company’s profitability. FDA regulated industries that produce products with a defined SAL are obligated to have adequately trained and knowledgeable staff or Subject Matter Experts (SMEs) within sterilization and sterility assurance to provide applicable regulatory guidance with the impacted systems.
This accredited training introduces both new and existing employees to sterilization by heat which includes Dry Heat and Moist Heat Sterilization processes. The role of sterilization by heat used for certain manufactured products, supplies and ancillary systems cannot be overemphasized. Having a clear understanding of the detailed requirements of the various types of sterilization by heat processes and their key impact on product material of composition is critical to determining the suitability of the application process to be employed.
This webinar describes the various types of dry and moist heat sterilization processes, types of equipment, functionality, operational ranges, validation requirements and the FDA’s inspection approach to sterilization process controls.
Upon completion of this course, you will be able to:
This training is part of the 10-course series required for the Cobblestone Sterilization Professional Certification Program. Attend this as a step in the certification process or as a stand-alone course for personal career advancement and training.
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This online training will benefit professionals working in the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device, Compounding Pharmacies, and In-vitro Diagnostics Product Manufacturing industries. It will be especially valuable for personnel and management within the following areas:
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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.Learn more
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